[PHARMACEUTICAL MANUFACTURING] PACOP VIOLET

Active Pharmaceutical Ingredients (API)

or bulk drug substance may be

discovered or obtained by

I. Synthetic biotechnology

II. Isolation from natural sources

III. Serendipitous new drug effect

discovery

a. I only b. III only c. I & II d. II & III e. I, II & III

e. I, II & III

Rx product life cycle phases that

involves regulatory submission for

additional dosage forms or new

therapeutic indications;

a. Discovery

b. Development

c. Commercialization

d. Termination

e. None of these

c. Commercialization

Which of the following phases of human

clinical testing match with their

prescription?

I. Phase I - testing the product in

larger groups in patients with

the disorder or disease

II. Phase II - testing may also take

place with special populations

such as renal or hepatic

impairment, pediatrics or

elderly subjects

III. Phase III - randomized,

controlled testing on large

patient populations to make

definitive assessment of drug

efficacy

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

b. iii only

4. Practice of pharmacy that involved

primarily with government regulations

and policies associated with all aspects

of products: a. Marketing Manager

b. Medical Information Specialist

c. Public Policy Specialist

d. Regulatory Affairs Manager

e. Product Representative

d. Regulatory Affairs Manager

Phase of human clinical trial testing that

assess dosing requirements:

a. Phase II

b. Phase IIA

c. Phase IIB

d. Phase III

e. Phase IV

b. phase iia

Particle size is a basic property of a

powder. Which of the following

expression of diameter that describes

the distance between pairs of parallel

tangents to the projected outline of the

particle in some fixed direction?

a. Martin's diameter, dm

b. Sieve diameter, da

c. Perimeter diameter, dp

d. Feret's diameter, df

e. Aerodynamic diameter, daero

d. feret's diameter

7. Expression of diameter that represents

the particle size of a powder having the

length of a chord equally dividing the

projected outline of the particle in some

fixed direction;

a. Martin's diameter, dm

b. Feret's diameter, df

c. Stokes diameter, dst

d. Equivalent volume diameter, dv

e. Sieve diameter, da

a. martin's diameter

8. This method is used to determine the

diameter of a sphere having the same

volume (V) as the particle (Equivalent

volume diameter, dv);

a. Sedimentation method

b. Anderson impactor method

c. Microscopic method

d. Coulter counter method

e. Light scattering method

d. Coulter counter method

9. Which method is widely used to

determine the crystallinity of a solid

powder?

a. Xray diffraction (XRD)

b. Angle of repose (a)

c. Photo correlation spectroscopy

(PCS)

d. None of these

e. All of these

​

- a. Xray diffraction (XRD)

10. If the % compresability of a powder is

23-35%, the powder flowability is ____

a. Extremely poor

b. Poor

c. Fair

d. Good

e. Excellent

B. POOR

11. The function of Material Inspection

Section in a manufacturing plant is:

I. To validate existing and

tentative procedures of testing

II. To sample and examine all raw

materials received

III. To maintain periodic

examination on the quality of

inventories throughout all

phases of storage, shipping and

distribution

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

D

12. A classification of defect which may

affect the function of the object and

therefore, may render the product

useless (eg.,presence of a crack in a

bottle):

a. Internal defect

b. Major defect

c. Minor defect

d. Critical defect

e. Variable defect

B.

13. A classification of defect which is not

seen although present:

a. Internal defect

b. Major defect

c. Minor defect

d. Performance defect

e. Attributable defect

A

14. A suppository that does not melt at body

temperature, is an example of what

defect? a. Attribute defect

b. Variable effect

c. Performance defect

d. Internal defect

e. Critical defect

C

15. The maximum percent defective of the

maximum number of defects per

hundred units that for purposes of

sampling inspection, can be considered

satisfactory as a process average;

a. Acceptable quality level

b. Risk of error

c. Consumer's risk

d. Producer's risk

e. None of these

A

16. The process of optimizing a drug

through the determination and/or

definiton of those physical and chemical

properties considered important in the

formulation of a stable, effective and

safe dosage form;

a. Batch formula

b. Master formula

c. Formulation

d. Preformulation

e. None of these

D

17. Purified water, USP is water obtained

by;

I. Distillation

II. Ion-exchange treatment

III. Reverse osmosis

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

E

18. Which of the following may be added in

syrup to retard crystallization of sucrose

or to increase the solubility of added

ingredients?

I. Glycerin

II. Sorbitol

III. Honey

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

C

19. Brady and whisky are example of spirits

that are prepared by:

a. Distillation

b. Maceration

c. Chemical reaction

d. Simple solution

e. Admixture

A

20. The emulsion is prepared by adding

water and oil alternately to the

emulsifying agent. This method of

preparation is:

I. Alternate addition method

II. English method

III. Soap method

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

C

21. The equipment used in the preparation

of emulsion wherein the dispersion of

two liquids is achieved by forcing the

mixture through a small inlet orifice at

high pressures.

a. Agitator or mechanical stirrers

b. Homogenizers

c. Ultrasonifiers

d. Colloid mills

e. Both A and C

B

22. A basic desirable property of a

suspension wherein the dispensed

phase should settle slowly without

forming a hard cake:

a. Slow sedimentation rate

b. Resuspendable or redispersible

c. Pourable

d. Chemical stable

e. Acceptable to the consumer

A

23. Mechanical properties of plastic

packaging material that has the ability to

withstand shock-loading, where a

specimen receives a blow from a

swinging pendulum as an example:

a. Tear strength

b. Flex resistance

c. Fatigue resistance

d. Impact strength

e. creep failure

D

24. The plastic processing method

employed for pharmaceutical packaging

components that is being heated to a

melted or viscous state and forced

under pressure through a die, resulting

in a configuration of desired shape:

a. Blow molding

b. Injection molding

c. Compression molding

d. Solvent casting

e. Extrusion

e

25. The selection and approval of a polymer

type is as important as the need to

check it routinely against the criteria

used in its selection. Which of the

following basic areas of control and/or

procedures are recommended?

I. Tissue-cell toxicity testing

II. Characterization analysis

III. Routinely inspect for

dimensional and attribute

variables

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

26. Which of the following is to be added to

make a flexible collodion?

I. Glycerin

II. Camphor

III. Castor oil

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

d

27. This refers to the quantity of dosage

form in the final packaging (excluding

the shipping carton) of a drug product

bearing the required labeling

information:

a. Pack size

b. Net content

c. Primary label

d. Lot number

e. Dosage strength

a

28. Which of the following is the appropriate

labeling format for products with multiple

API's?

I.

[Iron / Folic Acid]

Brand Name

II. [Iron +Folic Acid]

Brand Name

III. [ iron ]

[Folic Acid]

Brand Name

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

29. Which of the following special labeling

instructions is/are correctly paired with

their properties?

I. "Do not refrigerate or freeze" -

cannot tolerate excessive heat

II. "Store and transport not above

30ºC" - cannot tolerate freezing

III. "Store in dry conditions" -

hygrodcopic

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

b

30. Which of the following is/are correct

labeling format for product's

manufacturing and expiration date?

a. 03 Jun 2007

b. June 2007

c. 06/07

d. Both A and B

e. Both B and C

d

31. The caution statement, "Food, Drugs,

Devices, and Cosmetics Act prohibits

dispensing without prescription" shall

always be included in the:

I. Primary label including blister

pack and foil strip

II. Package insert

III. Unit carton

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

d

32. A pharmaceutical form of an active

ingredient or placebo being tested or

used as reference in a clinical trial:

a. Generic product

b. Investigational product

c. Formulation

d. Herbal products

e. Traditional products

b

33. For products that are intended for

external use, the statement "For

external use only" shall appear on all

labeling materials. Which of the

following is the correct format?

a. Capital letters against a red

background or printed in red font

b. Capital letters against a red

background or printed in black font

c. Capitalized each word and printed in

red font

d. Capitalized each word against a

black background and printed in

white font

e. Capitalized each word and printed in

black font

a

34. Which of the following is extremely to

the requisites provided by AO 2016-

0008?

I. Veterinary products

II. Drug products manufactured for

export

III. Investigational products

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

c

35. Which of the following is/are mandatory

information for blister packs/foil strips

packaging?

I. Name and/or logo of the MAH

on each unit for single API, or

every two (2) units for multiple

APIs II. Name and address of the

Manufacturer

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

c

36. Erweka testes, Schleuniger tester, and

Strong-Cobb tester are example of

devices used to test:

a. Tablet weight variation

b. Tablet hardness

c. Tablet disintegration

d. Tablet dissolution

e. Tablet content uniformity

b

37. These are synthetic derivatives (eg.,

esters and amides) of drug molecules

that may have intrinsic pharmacological

activity but usually must undergo some

transformation in vivo to liberate the

active drug molecule:

a. Molecular optimization

b. Prodrug

c. Preformulation

d. Investigational new drug

e. None of these -b

38. Which of the following factors can

directly contribute to content uniformity

problems in tablets?

I. Segregation of the powder

mixture or granulation during the

various manufacturing

processes

II. Non uniform distribution of the

drug substance throughout the

powder mixture or granulation

III. Tablet weight variation

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

39. The partial or complete separation of the

top or bottom crowns of a tablet form the

main body;

a. Lamination

b. Capping

c. Sticking

d. Picking

b

e. Mottling

40. The unequal distribution of color on a

tablet, with light or dark areas standing

out in an otherwise uniform surface;

a. Capping

b. Picking

c. Lamination

d. Mottling

e. Sticking

d

41. A term used to describe the surface

material from a tablet that is sticking and

being removed from the tablet's surface

by a punch:

a. Lamination

b. Sticking

c. Picking

d. Capping

e. Mottling

c

42. Tablet lamination or capping problems

are often aliminated by:

I. Addition of colloidal silica to the

formula

II. Slowing the tablet rate

III. Reducing the final compression

pressure

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

d

43. To overcome the mottling problem, the

preventive measure is:

I. The formulator may change the

solvent system

II. Change the binder system

III. Reduce the drying temperature

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

44. "Arching" or "bridging" and "rat-holing"

are problems associated with weight

variation of tablets, specifically:

a. Granule size and size distribution

before compression

b. Poor flow c. Punch variation

d. Hardness variation

e. Double compression

b

45. Granule density may influence the

following:

a. Compressibility

b. Tablet porosity

c. Surface tension

d. Both a & b

e. Both b & c

d

46. When the initial blend of powders is

forced into the dies of a large-capacity

tablet press and is compacted by means

of a flat-faced punches, the compacted

masses are called:

a. Slugs

b. Compaction rolls

c. Tablet presses

d. Both a & b

e. Both a & c

a

47. Which of the following tablet excipients

match with their example?

I. Binders - gelatin

II. Disintegrants - PEG

III. Diluents - stearic acid

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

a

48. Maillard reaction is:

a. Low concentrations of unbound

moisture

b. Forming a eutectic mixture

c. Form insoluble complexes and salts

d. Lead to browning and

discoloration with certain drugs

e. Containing tightly bound water but

having a low remaining moisture

demand

d

49. Advantage of mannitol as a talet diluent:

I. It is widely used in chewable

tablets

II. Relatively non hygroscopic

III. Excellent flow characteristics

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

-c

50. Dipac is a sucrose-based diluent

containing __ sucrose plus __ modified

dextrins:

a. 7%, 10%

b. 97%, 3%

c. 95%, 4%

d. 50%, 74%

e. 10%, 25%

b

51. The following are used as tablet

disintegrants, except:

a. Ethyl cellulose

b. Starch, USP

c. Primogel

d. Explotab

e. Ac-Di-Sol

a

52. Lubricants differs with anti-adherents

because lubricants are:

a. Reducing the sticking of any of the

tablet granulation or powder to the

faces of the punches or to the die

wall

b. Intended to promote flow of the

tablet granulation or powder

materials by reducing friction

between the particles

c. Intended to reduce the friction

during tablet ejection between the

walls of the tablet and the walls of

the die cavity in which the tablet

was formed

d. Both a & b

e. Both b &c

c

53. Syloid and Aerosil are materials used

as;

a. Glidants

b. Lubricants

c. Antiadherents

d. Flavors

e. Sweeteners

a

54. The purpose of this type of tablet is to

prevent the multiplication of bacteria in

the empty socket following a tooth

extraction by employing a slow releasing antibacterial compound or to

reduce bleeding:

a. Implantation tablets

b. Effervescent tablelts

c. Troches

d. Dental cones

e. Lozenges

d

55. The purpose of this tablet is to provide

prolonged drug effects, ranging from

one month to a year.

a. Sustained-release tablets

b. Implantation tablets

c. Dental cones

d. Vaginal tablets

e. Tablet triturates

b

56. Components of an effervescent tablets,

except:

a. Carbolic acid

b. Sodium bicarbonate

c. Citric acid

d. Tartaric acid

e. None of these

a

57. Vaginal tablets are also called ____

a. Packets

b. Implants

c. Inserts

d. Both a & b

e. Both b &c

c

58. The following type of tablets are rarely

used today, except:

a. Tablet triturates

b. Dispensing tablets

c. Hypodermic tablets

d. Effervescent tablets

e. None of these

d

59. Objectives of tablet coating include:

I. To control the release of the

drug from the tablet

II. To mask the taste, odor, or color

of the drug

III. To provide physical and

chemical protection for the drug

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

60. The following are the general types of

equipment used in most coating

processes, except:

a. The fluidized bed

b. The standard coating pan

c. The perforated coating pan

d. Day-Nauta processor

e. Air suspension

d

61. The basic sugar coating process

involves steps, except:

a. Syruping

b. Polishing

c. Bending

d. Subcoating

e. Sealing

c

62. The step in coating process that cover

and fill in the imperfections in the tablet

caused by subcoating step:

a. Polishing

b. Syruping

c. Subcoating

d. Bending

e. Sealing

b

63. The following are properties of an ideal

enteric coationg material, except:

a. Ease of application without

specialized equipment

b. Formation of a continuous film

c. Resistance to gastric fluids

d. Stability alone and in coating

solutions

e. Inability to be applied to

debossed tablets

e

64. Which of the following plasticizers is

used primarily for organic-based coating

solutions?

I. Spans

II. Castor oil

III. Propylene glycol

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

c

65. A commercially available colorants of

coating solution without additional milling equipment that gives opaquant

color concentrate for sugar coating:

a. Opalux

b. Opasparay

c. Opadry

d. Opagangnam

e. Opaquant-Extenders

a

66. These are very fine inorganic powders

used in the coating solution formulations

to provide more pastel colors and

increase film coverage:

a. Opagangnam

b. Opadry

c. Opaquant-extenders

d. Opaspry

e. Opalux

c

67. A film defect that caused by over wetting

or excessive film tackiness causes

tablets to stick to each other or to the

coating pan giving a "picked"

appearance to the tablet surface:

a. Roughness

b. Blistering

c. Cracking

d. Sticking and Picking

e. Orange-Peel Effects

d

68. A film defect that has a gritty surface

often observed when the coating is

applied by a spray:

a. Cracking

b. Sticking and picking

c. Roughness

d. Bridging and filling

e. Orange-Peel Effects

c

69. A film defect that resulted from

inadequate spreading of the coating

solution before drying causes a bumpy

effect on the coating:

a. Orange-Peel Effects

b. Hazing/Dull film

c. Roughness

d. Blistering

e. Bridging and filling

a

70. During drying, this film defect may

shrink and pull away from the sharp

corners of an intagliation or bisect and

results in a thick film that fills and

narrows the monogram or bisect that is

caused by applying too much solution.

a. Hazing/Dull film

b. Cracking

c. Blistering

d. Color variation

e. Bridging and filling

e

71. When coated tablets require further

drying in ovens, too rapid evaporation of

the solvent from the core and the effect

of high temperature on the strength,

elasticity and adhesion of the film may

result this defect.

a. Cracking

b. Bridging and Filling

c. Roughness

d. Blistering

e. Color Variation

d

72. This film defect is sometimes called

bloom because it can occur when too

high a processing temperature is used

for a particular formulation:

a. Blistering

b. Hazing/Dull film

c. Cracking

d. Orange-Peel Effects

e. Sticking and Picking

b

73. The film defect problem can be caused

by processing conditions or the

formulation:

a. Color variation

b. Bridging and Filling

c. Cracking

d. Roughness

e. Blistering

a

74. This film defect occurs if internal

stresses in the film exceed the tensile

strength of the film:

a. Cracking

b. Color variation

c. Roughness

d. Blistering

e. Orange-Peel Effects

a

75. The specialized coating is an efficient

method of applying coating to

conductive substrates:

a. Vacuum Film Coating

b. Dip Coating

c. Electrostatic Coating

d. Compression Coating

e. None of these

c

76. This type of specialized coating requires

a specialized tablet machine:

a. Vacuum film coating

b. Dip coating

c. Electrostatic coating

d. Compression coating

e. None of these

d

77. This specialized coating is applied to the

tablet cores by dipping them into the

coating liquid:

a. Vacuum film coating

b. Dip coating

c. Electrostatic coating

d. Compression coating

e. None of these

b

78. This is a new specialized coating

procedure that employs a specially

designed baffled pan:

a. Vacuum film coating

b. Dip coating

c. Electrostatic coating

d. Compression coating

e. None of these

a

79. This component is added to most tablet

formulation to facilitate the breakup of

the tablet when it comes in contact with

water in the GIT:

a. Lubricant

b. Disintegrants

c. Binders

d. Diluents

e. Glidants

b

80. Thia is tablet component that make up

the major portion of the tablet:

a. Binders

b. Diluents

c. Disintegrants

d. Lubricants

e. Dyes

b

81. PVP in alcohol, ethylcellulose, methyl

cellulose in chloroform will bind what

characterisics of drugs?

a. Heat-sensitive

b. Heat-resistant

c. Water-sensitive

d. Water-resistant

e. Both a and d

c

82. A maximum of ___ of soluble dye is the

"rule of the thumb" in concentration of

colorants to be used:

a. 0.01%

b. 0.02%

c. 0.03%

d. 0.04%

e. 0.05%

c

83. The dry method for preparing tablet

is/are composed of:

a. Direct Compression

b. Granulation of Compression

c. Wet Granulation

d. Both a and b

e. Both b and c

d

84. A tablet processing problem that

resulted from the removal of edges of

tablet:

a. Capping

b. Lamination

c. Chipping

d. Mottling

e. Picking

c

85. A type of mechanical hardness tester

that operates with the same principle as

applies:

a. Eureka instrument

b. Stokes Monsato

c. Strong Cobb

d. Pfizer Hardness tester

e. None of these

d

86. The USP limit for content uniformity:

a. 70-100%

b. 65-95%

c. 50-100%

d. 100-120%

e. 85-115%

e

87. The general advantages of multilayered

tablets are, except:

a. Two incompatible drugs may be

kept separate by interposing an inert

substance between them

b. Each layer may have a separate

color for identity

c. Accurate control of the delayed

action portion of tablets is possible

d. All of these

e. None of these

e

88. The general method of preparing

effervescent tablets:

a. Wet fusion

b. Heat fusion

c. Cold fusion

d. Both a and b

e. Both c and d

d

89. The sustained release tablets are

intended to provide:

I. Absorption through the oral

mucosa for immediate release

of the medication

II. Immediate release of an amount

of drug that promptly produces

desired therapeutic effect

III. Gradual and continual release

of the other amounts of drug to

maintain this level of effect

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

d

90. The essential property to be possessed

by tablet granulation is:

I. Fluidity

II. Compressibility

III. Plasticity

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

c

91. This additive/s and component/s added

to formulation of tablets:

a. Binders

b. Disintegrants

c. Diluents

d. Lubricants

e. All of these

e

92. Method of preparing components for

tablet comprpession include:

I. Heat methods

II. Wet methods

III. Dry methods

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

d

93. Component of film coating solution that

provides water permeability

a. Cellulose acetate phthalate

b. Polyethlylene glycol

c. Plasticizer

d. Surfactant

e. Colorants

b

94. Polyoxyethylenesorbitian is an example

of ___ that enhance spreadability of the

film during application:

a. Plasticizer

b. Cellulose acetate phthalate

c. Colorants

d. PEG

e. Surfactant

e

95. The function of this component of

coating solution is to form a smooth thin

film under ordinary coating process:

a. Surfactant

b. Polyethylene glycol

c. Cellulose acetate phthalate

d. Plasticizer

e. Colorants

c

96. Castor oil is an example of ____ that

produce flexibility and elasticity of the

tablet coating:

a. Plasticizer

b. Colorants

c. Cellulose acetate phthalate

d. Surfactant

e. PEG

a

97. These are added to film coating to make

the tablet elelgant and distinctive:

a. PEG

b. Cellulose acetate phthalate

c. Plasticizer

d. Colorants

e. Surfactant

d

98. According to USP, it is a state in which

any residue of the tablet, except the

fragments of insoluble coating remains

on the screen is a soft mass having no

firm core:

a. Friability

b. Weight variation tolerance

c. Content uniformity

d. Disintegration time

e. Tablet thickness

d

99. Disintegration apparatus:

I. Constant heat

II. Basket

III. A motor with lever

a. I only

b. III only

c. I & II

d. II & III

e. I, II & III

e

100. The equipment used in

spheronization:

a. Homogenizer

b. Agitator machine

c. Colloid mills

d. Marumerizer machine

e. Mechanical stirrer machine

d